Tamsulozin-LF

General characteristics. Structure:

Active ingredient: 0,4 mg of a tamsulozin of a hydrochloride.

Excipients: sugar granules, a medicinal covering L100 (methacrylic acid - methylmethacrylate copolymer), a macrogoal 6000, ethyl cellulose.

Structure of a solid gelatin capsule: crimson 4R (Е 124), orange yellow (E 110), quinolinic yellow (Е 104), patent blue V (Е 131), titanium E 171 dioxide, gelatin.

Indications to use:

Route of administration and doses:

For intake. To adults and children 18 years are more senior it is recommended to accept on 1 capsule a day - after a breakfast, washing down with enough water, not chewing and without breaking.

Patients with an abnormal liver function and kidneys. At a renal failure, and also at a slight and moderate liver failure correction of the mode of dosing is not required.

Features of use:

As well as at use of other blockers of alfa1-adrenoceptors, in some cases at use Tamsulozina-LF decrease in the ABP which can sometimes lead to a loss of consciousness is possible. At emergence of the first symptoms of orthostatic hypotension (dizziness, weakness) the patient has to accept horizontal position before disappearance of above-mentioned symptoms.

Before beginning treatment Tamsulozinom-LF, it is necessary to undergo medical examination for the purpose of detection of other associated diseases which the same symptoms as a benign hyperplasia of a prostate can cause. Before an initiation of treatment it is necessary to conduct rectal examination of a prostate and if necessary – the test for determination of level of a specific antigen of a prostate (PSA) before and through the identical periods during treatment. It is necessary to appoint drug to patients with a heavy renal failure (clearance of creatinine <10 ml/min.) with extra care as clinical trials from uses of a tamsulozin at such patients were not conducted.

In rare instances when using a tamsulozin it was reported about development of a Quincke's disease at which emergence, treatment tamsuloziny should be stopped immediately, for the patient observation before disappearance of hypostasis has to be established, тамсулозин repeatedly do not appoint.

At some patients who accepted or accept тамсулозин, during surgical intervention on removal of a cataract noted a syndrome of an atonic iris (ISAR) that there can be the reason a uvelichesniya of quantity of complications when carrying out such operation. For this reason for patients to whom cataract surgery is planned, are not recommended to appoint тамсулозин. As a rule, in 1-2 weeks prior to carrying out operation for removal of a cataract it is recommended to stop treatment tamsuloziny. However expediency and terms of the termination of reception of a tamsulozin are definitely not established for today. At a preparation for surgery surgeons-ophthalmologists have to find out whether the patient тамсулозин for the purpose of the prevention of the possible complications connected with ISAR accepted (or accepts).

Drug is appointed only for treatment of men. Do not apply at children aged up to 18 years.

Researches of influences of drug on ability to manage vehicles or to work with other mechanisms did not carry out. Patients have to be warned about possibility of dizziness.

Side effects:

Frequency of undesirable reactions which were observed or during conduct of clinical trials or were received from spontaneous messages on development of undesirable reactions is defined as follows: often (> 1/100 - <1/10); infrequently (> 1/1000 - <1/100); seldom (> 1/10 000 - <1/1000); very seldom (<1/10 000), it is unknown (frequency cannot be determined by the data which are available for today).

Frequent side effects.
From TsNS: dizziness (1,3%);
from reproductive system: disturbances of an ejaculation.

Infrequent side effects.
From TsNS: headache;
from CCC: heart consciousness, postural hypotension;
from respiratory organs, a thorax and mediastinum: rhinitis;
from a GIT: lock, diarrhea, nausea, vomiting;
from skin and mucous membranes: skin rash, small tortoiseshell, itch;
disorders of the general character: adynamy.

Rare side effects.
From TsNS: faints;
from skin and mucous membranes: Quincke's disease.

Very rare effects.
From a reproductive system: priapism;
from skin and mucous membranes: Stephens-Johnson's syndrome.

Cases of intraoperative instability of an iris of the eye of an eye (syndrome of a miotic pupil) at operation for a cataract at patients who accepted long time тамсулозин are described.

Interaction with other medicines:

At simultaneous use of a tamsulozin of a hydrochloride with atenoly, enalapril, nifedipine or theophylline of medicinal interaction did not note. Simultaneous use with Cimetidinum raises, and with furosemide reduces concentration of a tamsulozin in a blood plasma, but as these levels remain within norm, in special dose adjustment of a tamsulozin there is no need.

In the researches in vitro diazepam, propranolol, трихлорметиазид, хлорматинон, amitriptyline, diclofenac, glibenclamide, симвастатин and warfarin do not influence free fraction of a tamsulozin in a blood plasma. In this way тамсулозин does not change the level of free fractions of diazepam, propranolol, a trikhlormetiazid and hlormadinon in a blood plasma of the person.

In the researches in vitro interactions at the level of hepatic metabolism with the assistance of microsomal fractions in a liver (the system of enzymatic metabolism with the participation of P450 cytochrome was indicative) concerning amitriptyline, salbutamol, glibenclamide and a finasterid were not revealed. However diclofenac and warfarin can accelerate elimination of a tamsulozin from a blood plasma.

Co-administration of a tamsulozin with strong inhibitors of an isoenzyme CYP3A4 can lead to increase in concentration of a tamsulozin. Co-administration with ketokonazoly led to increase in AUC and Cmax of a tamsulozin in 2,8 and 2,2 times respectively. It is not necessary to use a combination тамсулозин with strong CYP3A4 inhibitors at patients with disturbance of metabolism of an isoenzyme of CYP2D6. drug should be used with care in a combination with strong and moderate CYP3A4 inhibitors.

Led co-administration of a tamsulozin and paroksetin to increase in AUC and Cmax of a tamsulozin in 1,3 and 1,6 times respectively, however this increase is recognized as clinically insignificant.

Simultaneous use with other blockers of alfa1-adrenoceptors can strengthen hypotensive effect.

Contraindications:

- hypersensitivity to active agent or any of auxiliary components of drug;
- orthostatic hypotension (including in the anamnesis);
- the expressed liver failure.

With care:
- heavy renal failure (clearance of creatinine less than 10 ml/min.).

Overdose:

Cases of acute overdose tamsuloziny are noted.

Symptoms: possible development of acute decrease in the ABP and compensatory tachycardia.

Treatment: symptomatic, it is necessary to carry out the maintenance therapy directed to recovery of normal function CCC (for example, the patient needs to accept horizontal position). If this measure does not work, carry out infusional therapy and appoint angiotonic means. It is necessary to watch for functions of kidneys and to carry out the general maintenance therapy. Owing to high extent of linkng of a tamsulozin with proteins of a blood plasma carrying out a hemodialysis is inexpedient. For the purpose of the termination of further absorption of drug it is possible to cause vomiting artificially. At overdose of a significant amount of drug the patient needs to wash out a stomach using absorbent carbon and low-osmotic purgatives, such as sodium sulfate.

Storage conditions:

In protected from moisture and light the places not available to children, at a temperature not above 25 °C. Period of validity 2 years.

Issue conditions:

According to the recipe

Packaging:

On 10 capsules in a blister strip packaging. On the 3rd blister strip packagings in a cardboard pack together with the application instruction.